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DESI (Drug Efficacy Study Implementation) Less than effective (LTE) drugs

drugs that the Food and Drug Administration (FDA) has proposed to withdraw from the market in a notice of opportunity for a hearing (NOOH) because there is a lack of substantial evidence of effectiveness for all labeled indications. Any identical, related or similar (IRS) drugs to those LTE drugs subject to the NOOH are also included in this provision. Many of these drugs have been unknowingly paid for by federal and state funded healthcare programs, although the LTE determinations were made decades ago in Federal Register notices. See also Unapproved New Drugs in this Glossary.

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